Meaningful Activity Intervention for Persons With Mild Cognitive Impairment

NCT01843283 | Completed Phase 1 DMC

• 1 other identifier: 1R21NR013755-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to evaluate the feasibility of and satisfaction with the revised DEMA and to estimate effect sizes for DEMA through incorporation of a comparison group. Specific aims are as follows: Aim 1: Evaluate feasibility of the study for MCI patient/caregivers. Aim 2: Estimate effect sizes for DEMA on MCI patient and caregiver outcomes. Aim 3: Evaluate MCI patients and family caregivers' satisfaction with and perceptions of DEMA or IS.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Family Caregivers; Intervention studies

Outcome Measures

Primary Outcomes (1)

• Patient_Depression symptoms: Patient Health Questionnaire Depression Scale (PHQ-9)

  Change in depression from baseline to immediately (two-week)- and 3 months post-intervention

Secondary Outcomes (9)

• Patient_satisfaction with communication: The subscale of Communication and Affective Responsiveness

  Change in satisfaction with communication from baseline to immediately (two-week)- and 3 months post-intervention

• Patient_Physical Function: Alzheimer disease cooperative study activities of daily living inventory.

  Change in physical function from baseline to immediately (two-week)- and 3 months post-intervention

• Patient_Life satisfaction : Life Satisfaction Index for the Third Age-Short Form

  Change in life satisfaction from baseline to immediately (two-week)- and 3 months post-intervention

• Patient_Satisfaction with program: Satisfaction with Meaningful Activity Program Scale is adapted from the Caregiver Satisfaction Scale

  It will be collected at 3 months post-program evaluation

• Patient_ Meaningful activities engagement performance and satisfaction: Canadian Occupational Performance Measure & weekly log

  Change in meaningful activities engagement performance and satisfactionfrom baseline to immediately (two-weeks)- and 3 months post-intervention

Study Arms (2)

Daily Enhancement Meaningful Activity (DEMA)

EXPERIMENTAL

The group member will receive Self-management Toolkit and 6 bi-weekly individualized sessions, 2 face-to-face and 4 via telephone delivered by a trained intervener. DEMA will provide autonomy support by helping patients to identify and prioritize activities, classify needs and goals, generalize manageable solutions, engage in self-selected activities under family support, and self-evaluate failure and success or renew problem-solving as needed.

Behavioral: Daily Enhancement Meaningful Activity (DEMA)

Information Support (IS)

ACTIVE COMPARATOR

The IS group will receive 2 face-to-face meetings to receive an overview of what will happen in the study and an initial Alzheimer Association, educational brochure. Then they will receive 4 biweekly follow-up phone calls and have the opportunity to ask only questions related to the educational materials.

Behavioral: Information Support (IS)

Interventions

Daily Enhancement Meaningful Activity (DEMA) BEHAVIORAL

Daily Enhancement Meaningful Activity (DEMA)

Information Support (IS) BEHAVIORAL

Information Support (IS)

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MCI patients:
• are aged 60 years or older,
• speak English,
• have both caregiver-reported, clinically significant decline in cognition and clinician-detected or research based cognitive impairment on the standardized health exam
• have at least one cognitive assessment score below the 7th percentile
• have a normal range in performance of daily living tasks based on informant interview information indicating that impairment does not rise to the level of dementia.
• Family caregivers:
• are adults ≥ 21 years of age;
• have primary responsibility for providing unpaid care to an MCI relative, along with monitoring safety and providing social support
• are able to read and speak English
• are oriented to persons, places, and time \[having a 6-item Mini-Mental State Examination (MMSE) score of 4 or above\]

You may not qualify if:

• MCI patients and family caregivers will be excluded if:
• the MCI patient or family caregiver has a diagnosed bipolar disorder or untreated schizophrenia;
• the family caregiver has significant cognitive impairment that may hinder participation (6-item MMSE \< 4)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yvonne Lu, PhD

  IU School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: April 30, 2013
• Study Start: July 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

US (1)